| CTRI Number |
CTRI/2025/06/088725 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Explore the Link Between Prakriti that is body type of a person and Dyslipidemia and to Evaluate the Role of Prakriti in Its Manifestation |
|
Scientific Title of Study
|
An Observational Study To Evaluate The Association Between Daihik Prakriti And Dyslipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Meena |
| Designation |
PG Scholar Department Of Kriya Sharir |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal |
| Address |
Room No 14 Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal Science Hills Nehru Nagar Kolar Bypass Road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8226045504 |
| Fax |
|
| Email |
priyankameena8225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Sharma |
| Designation |
Professor |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal |
| Address |
Room Number 14 Department Of Kriya sharir Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal Science Hills Behind MANIT Nehru Nagar Kolar Bypass Road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893352450 |
| Fax |
|
| Email |
drbabitasharma5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Meena |
| Designation |
PG Scholar Department Of Kriya Sharir |
| Affiliation |
Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal |
| Address |
Room Number 14 Department Of Kriya sharir Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal Science Hills Behind MANIT Nehru Nagar Kolar Bypass Road Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8226045504 |
| Fax |
|
| Email |
priyankameena8225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal Madhya Pradesh India Pincode 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College Institute Bhopal Mp |
| Address |
Science Hills Behind MANIT Nehru Nagar Kolar Bypass Road Bhopal Madhya Pradesh India Pincode 462003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Meena |
Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Bhopal |
OPD AND IPD OF Kayachikitsha Department of Pt Khushilal Sharma Government Autonomous Ayurveda College & Institute Science Hills, Nehru Nagar, Kolar Bypass Road, Bhopal
Bhopal
MADHYA PRADESH |
8226045504
priyankameena8225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PTKLS Ayurveda Institute Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOR, (2) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, (3) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, (4) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with dyslipidemia
Participants aged between 21 to 60 years without any discrimination of gender caste and religion
Participants willing to participate in the study and to give written consent |
|
| ExclusionCriteria |
| Details |
Person of age less than 21 years and above 60 years
Person with any cardiac disease, life threatening disease like MI CHF COPD CVA Cirrhosis of liver and malignant diseases
Person with major psychiatric illness.
Drug induced dyslipidemia.
Person taking drugs like corticosteroids, tricyclic, anti depressant, cycloheptadine which leads to weight gain.
Person with Sever systemic illness.
Participants not willing to give written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In present study, an attempt is made to evaluate the role of Prakriti in the manifestation of dyslipidemia. Our goal is to provide clarity on the link between Daihik Prakriti and dyslipidemia
|
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dyslipidemia is one of the burning problems in todays era. Lipid & lipoprotein abnormalities are extremely common in general population. Dyslipidemia is established and modifiable risk factors for CHD. Cardiovascular disease which encompasses conditions such as coronary heart disease, stroke, peripheral artery disease, is the leading cause of mortality worldwide Dyslipidemia remains asymptomatic and undetected until a complication occur such as myocardial infarction due to early atherosclerosis. there is an urgent need to prevent and manage dyslipidemia. For this purpose the tool of Ayurveda namely Prakriti could be very helpful. By doing Prakriti assessment of a dyslipidemia patient, we would get the Prakriti most susceptible to dyslipidemia. The Prakriti most susceptible, would guide us in the prevention, prognosis and management of dyslipidemia. In present study, an attempt is made to evaluate the role of Prakriti in the manifestation of dyslipidemia |